With due respect and awe..
OPEN LETTER TO PROFESSOR OF MEDICAL ETHICS AND LAW - UK, by Alison Fisheron March 12, 2011 at http://fb.me/UPPAmjIt
Dear Professor Harris,
Ethical problems arising from a paradigm shift that Multiple Sclerosis may be vascular in origin and not the autoimmune disease it is presently assumed to be.
A Dr Zamboni has discovered that blood is refluxing into the brains and spinal columns of over 95% of people with MS (PwMS) due to congenital malformations in our vascular system, mainly in the internal jugular and azygos veins (CCSVI).
Treatment for CCSVI is balloon angioplasty, a procedure founded by Dr Gruentzig and swiftly adopted into the world's medical practice in the 1970s without any double blinded, randomised controlled trials. I believe it took about five years of actually treating people for a consensus to be reached on the optimum protocol for using Dr Gruentzig's techniques.
Dr Zamboni and Dr Zivadinov, whose own research supports Zamboni's work, presented their work to a very hostile audience of neurologists at the American Neurological Society last year. I was very struck by them choosing a photo of an elephant to illustrate the following slide:
"It is imperative we acknowledge a classical ethical tension.... on steroids. Scientifically rigorous research alongside respect for patient needs and rights"
Did they mean the elephant in the room or elephants don't forget? I interpreted the elephant as a warning myself. Venous theories behind MS have been suggested by scientists since Victorian times.
"Reflux, revolution and the role of forgotten research"
Now we have the imaging technology to prove those theories. However Dr Zamboni's work has been subjected to the Semmelweiss Reflex by neurologists, most notably by neurologists with research backed by pharmaceutical companies with enormous MS drugs markets.
"The Semmelweiss Reflex" Definition: Mob behavior which occurs when a discovery of scientific fact is punished rather than rewarded.
Semmelweiss ended up being committed to an asylum as other doctors resisted his attempts to introduce handwashing to prevent women dying in childbirth from puerperal fever (the other doctors put him down saying 'doctors are gentlemen and gentlemen don't have dirty hands').
Another more recent example of a medical paradigm shift is Dr Barry Marshall who had to give himself a stomach ulcer to prove that bacteria caused ulcers. http://www.bbc.co.uk/news/health-11686825
Paradigm shifts happen and those of us with MS are short on time to reap the benefits of our paradigm shift.
The reason I am writing to you is that I heard you on BBC Radio 4, last April, commenting on ethical issues surrounding the treatment of children at Great Ormond Street Childrens' Hospital.
Second item at 13mins 20 seconds.
I was very ill in bed at the time as a result of my MS, suffering extreme fatigue and experiencing such difficulties with mobility that I had to go up and down stairs on my bottom. I think it was a fortunate coincidence that I decided to try out the radio setting on my IPOD for the first time and heard the broadcast.
I made a mental note to listen to the programme again on i-player and I finally got round to it today.
In the case of a premature baby born without a windpipe the presenter Jenny Murray wondered whether or not it was appropriate to (push the boundaries and ) try a really new surgery and asked:
"how important is it... for medical advances to push the barriers and make these difficult decisions?"
I liked your reply (at 22 minutes):
"well of course we always have to do something for the first time and when we do it for the first time it isn't always known what the outcome will be, not even when we do it for the second or the third time.
And everybody, everybody in this country, and everybody in the world actually, has benefited from medical advances which have been tried out for the first time when there were lots of things that were not known. So it is essential.
But as Dr C rightly says it is also essential that we don't do this at the expense of the interests of the particular individuals on whom new procedures or new therapies are tried.
But very often they will be therapies of last resort and the individual will have exhausted all of the other things which might have worked for them. And therefore it is often justified, precisely because it is that or nothing"
I think your comments may be highly relevant to the situation developing worldwide in respect of people with MS (PwMS) who are seeking treatment for the venous condition (CCSVI). I am involved in a campaign to make angioplasty (venoplasty) treatment for CCSVI available in the NHS as soon as possible.
I believe people are being denied investigation and treatment on discriminatory grounds - because we happen to have a diagnosis of MS.
Hundreds of British PwMS are now travelling to private clinics abroad (or one private clinic in Scotland) for angioplasty (venoplasty) on stenoses in their internal jugular veins, azygos veins and, if they are lucky enough to have a full assessment, some are also found to require venoplasty on their iliac vein (May Thurner syndrome, which is already treated in the NHS).
One estimate now puts the number of people treated worldwide for CCSVI at around 15,000.
We are way beyond the first, second and third times.... The vascular doctors and cardiologists treating us confirm the incidence of vascular abnormalities in PwMS at 95% and above.
The morning I heard you on Radio 4 I thought my life was over due to MS. As a widow with two girls I was starting to make plans for carers to help me rather than have my children take on my care. I have no plans to take on carers now. I am one of the people who has travelled abroad for treatment. I was treated in Poland in September 2010. My MS symptoms have improved enormously. A physiotherapist has written to my neurologist with clinically objective measures of some of my improvements - she assessed me before and after my procedure. My crippling fatigue is gone, my cognition is improved and my balance is measurably better.
Due to more publicity in Canada this debate is now raging in much higher medical and political arenas than at present in the UK.
The following is a pdf document of a statement made to a Canadian Standing Committee on Health by a Canadian Vascular Surgeon, Dr Sandy McDonald, who is appalled that he has been prevented from treating PwMS with vascular symptoms and conditions solely on the grounds that they have MS. This statement is useful as it also summarises the medical issues involved by way of background.
I met Dr McDonald when he attended a medical conference on CCSVI in Glasgow in October 2010, a very compassionate doctor I sense a steely core within him and he is an excellent advocate for us. No doubt he is all too well aware of the $10billion worldwide MS drugs market which is at risk as a result of Dr Zamboni's work.
http://www.articleshub.org/article/211/ ... tiple-Sc..
He may also be aware that neurologists may be experiencing a severe case of gatekeeper syndrome on top of their Semmelweiss Reflex! One Professor of Pyschology has defined gatekeeper syndrome as 'lack of interest in anything, no matter how important to your work, that doesn’t involve you being a gatekeeper'.
The size of the MS drugs market, the attitudes of neurologists and the bewildering stance of worldwide MS Societies are fundamental background issues to the discrimination which PwMS are now facing in obtaining investigation and treatment for venous/vascular conditions.
A Dr Schelling also attended the CCSVI conference in Glasgow. He tried repeatedly in the 1980s to obtain research funding for venous theories behind MS and failed. Pharmaceutical companies provide most of the research funding available and of course they did not (do not) want to know about a simple surgical procedure helping us. Dr Schelling is thrilled that, with modern imaging techniques, Dr Zamboni is confirming his theories. It was nice to thank Dr Schelling for his work and to tell him in person that treatment has made an enormous difference to my life. He shook his head and said that he still felt sad for the tens of thousands of PwMS who have suffered or died since he failed to secure funding to advance his theories.
At that same conference I also met a Scottish vascular surgeon, who was willing to treat PwMS in the NHS who had been referred to him with stenosed veins at a hospital in Scotland last year. He is unhappy that NHS Managers prevented him from treating people if they had a diagnosis of MS. He is now treating people privately at a clinic in Scotland.
My own experience of seeking treatment in the NHS and my subsequent thoughts following treatment in Poland are contained in the following blogs.
Home Truths - contains details of venous conditions which are treated in the NHS provided you don't have MS!
http://www.ms-ccsvi-uk.org/home/files/m ... svi-uk.pdf
Born to Run in Poland, Wheelchairs and steroids in the UK http://www.ms-ccsvi-uk.org/home/files/m ... to-run.pdf
A Vascular Professor has confirmed that the simple procedure I underwent in Poland is performed in other patient groups in the NHS and is not considered to be 'dangerous'. The procedure is commonly described as dangerous by some neurologists and others with vested interests in maintaining the old (unproven) autoimmunity paradigm for MS.
I attach a photograph showing balloon angioplasty in the IJV of a kidney dialysis patient - Parts A to C the photograph could be my treatment, both of my IJVs were ballooned in the same position. Am I supposed to believe that it would have been uniquely 'dangerous' for me as a PwMS to have my procedure carried out in my local hospital rather than trek to Poland and pay £5000 for the treatment I needed?
A Vascular Professor was rather shocked to hear that another MS patient (who has also been refused balloon angioplasty for stenosed IJVs in the NHS) is not willing to stay on his current MS medication,Tysabri, beyond next February.
The reason for this is that after two years patients face an unacceptable level of risk of developing a brain virus called PML. Biogen has to report deaths and incidence of PML to the New York Stock Exchange - 20 deaths from PML so far.
http://online.wsj.com/article/BT-CO-201 ... 18604.html
The patient has also now been treated in Poland for stenosed IJVs. It is that patient's view that Tysabri (which costs the NHS £30,000+ per patient per annum) achieved next to nothing in comparison with the very positive relief of his MS symptoms immediately following venoplasty.
Why has the risk v benefit analysis of a simple medical procedure, balloon angioplasty, been re-calibrated for PwMS? This recalibration might be in the interests of neurologists or the pharmaceutical companies but it is most certainly NOT in the interests of MS patients.
Neurologists and the pharmaceutical industry are happy to treat us based on "unproven" autoimmune theories, though none of the drugs appear to have altered the long term disability outcomes of PwMS:
Source: CCSVI in Multiple Sclerosis
Remember, the autoimmune theory of MS is still just a theory. Doctors have never proven that MS is started by the immune system.
Here is a wonderful editorial on this topic by Dr. Peter Behan, called
"The Futility of the autoimmune orthodoxy in multiple sclerosis research"
"...a false orthodoxy claiming that multiple sclerosis is an autoimmune disorder has developed and formed the present basis of treatment, drug trials and research. The outcome of this misplaced creed has been truly catastrophic.”
Please refer to the following leaflet made available to patients at the John Radcliffe Hospital in Oxford:
http://www.oxfordradcliffe.nhs.uk/forpa ... plasty.pdf
It relates to venoplasty and stenting in the Superior or Inferior Vena Cava (veins). Apart from the title the leaflet could be written for the procedure I had performed in Poland in my Internal Jugular Veins. I see nothing in the small print of this leaflet suggesting that the procedure cannot be performed in people who have MS.
There may be a case to be made under the Equality Act but good litigation lawyers do not tend to work on Legal Aid and many PwMS are unable to work anymore. Examples of discrimination against PwMS I have are as follows:
- a letter to a neurologist from a hospital imaging department indicating that Duplex studies of the Cerebral Veins in Multiple Sclerosis patients (requested by the neurologist!!) are not available to PwMS;
-letter from a vascular consultant to a patient (who had been referred by his GP after providing evidence of blocked internal jugular veins from a private scan) stating that he would see the patient and discuss the evidence he had of stenoses but only if the patient understands that no treatment will be available.....;
- another letter from a vascular consultant refusing follow up treatment to someone who had been abroad for initial treatment for CCSVI.
I am aware of several others who have been referred by helpful GPs to vascular consultants only to be refused investigation and treatment at that next hurdle specifically because they have MS.
I am aware of a PwMS who suffers excruciating nerve pain who obtained wonderful clear images of stenosed IJVs from a German vascular clinic nearly a year ago. He has been refused investigation or treatment of his condition in the NHS and cannot afford private treatment.
I am aware of several people who have forced their GPs to refer them to vascular consultants. A couple used arguments from my Home Truths and others more pointedly referring to discrimination under the Equality Act or general reminders of their doctors' Hippocratic Oath and duty of care!
Many people have been belittled by neurologists and other health professionals for even having the audacity to ask about CCSVI. Some of these conversations have been recorded and I wouldn't care to be one of those neurologists sitting in a GMC hearing listening to their comments being played back to them.
The whole situation is unsavoury to say the least. PwMS can be a desperate bunch, my brush with MS has only run three years and I completely understand why that is the case. It is a hideous disease and many of us have saved Dignitas in our computer 'favourites' by way of a mental coping strategy that if things got too bad at least we could cop out.
Many people have killed themselves because of their MS over the years.
Dignitas: I couldn’t let him die alone
Four years ago Laura McDaid made the hardest choice of her life: to accompany her former boyfriend to Switzerland’s Dignitas clinic to escape the pain of MS.
Multiple sclerosis sufferer took his own life while on holiday
I feel particularly sad about the second man as I read about him while I was recovering from my own CCSVI treatment, maybe he didn't even find out about the real hope that treatment for CCSVI offers us.
It is one of the reasons that I sit writing to you now instead of simply getting on and enjoying my new life. Survivor guilt perhaps. Guilt that I had sufficient cognition left to find out about CCSVI and the money to buy my way out of a wheelchair. There are people borrowing from family and friends, fundraising via the internet and even remortgaging their houses to travel abroad for a treatment which is available for non MS patients in their local hospitals.
Patient Body Helpful?
Rather sadly the MS Society is an archaic, paternalistic organisation which in my opinion is more of a marketing arm of the pharmaceutical industry than an organisation acting in the best interests of its members.
http://www.ms-ccsvi-uk.org/home/files/m ... -drugs.pdf
Page 71 onwards of the following document sums it all up.
http://www.parliament.the-stationery-of ... /42/42.pdf
The MS Society has next to nothing to offer by way of meaningful information on CCSVI, is poorly informed and so far has simply spouted the opinions of neurologists who have obvious conflicts of interests with large research projects funded by MS drug companies. When replying to our queries on CCSVI MPs and Dept of Health officials have repeatedly quoted the MS Society's medical advisors (I believe the following quote was from Professor Alastair Compston):
"we are all agreed that people with MS are not likely to benefit by treatments that dilate blood vessels and consider these procedures to carry risks with no evidence for benefit".
I believe this statement confirms that Professor Compston, a neurologist, has no vascular experience whatsoever. If we are to respect his views as an MS expert perhaps we need reassurance that he has now at least read the following research:
Vascular comorbidity is associated with more rapid disability progression in multiple sclerosis.
Marrie RA, Rudick R, Horwitz R, Cutter G, Tyry T, Campagnolo D, Vollmer T. Neurology. 2010 Mar 30; 74(13):1041-7.
Would Professor Compston care to argue that an MS patient with heart problems would not benefit from having his coronary arteries dilated with balloon angioplasty either? Or that vascular doctors leave May Thurner or Budd Chiari venous conditions untreated if they present in the MS patient population?
Last year when we were collecting signatures for a CCSVI petition to the Government the MS Society wrote to its local branch leaders advising them not to circulate the petition to members of the Society and not to sign it themselves.
The MS Society has repeatedly deleted posts on their Facebook page which contained scientific papers and evidence about CCSVI and many people have been banned outright. On occasions they have tolerated one of their research volunteers posting libellous and abusive comments about people writing about CCSVI. Censorship is alive and well in our patient body when the topic of CCSVI is raised. The same curious situation exists within the Canadian and US MS Societies.
The MS Society did not send anyone to the CCSVI conference in Glasgow last year so they missed the opportunity to discuss CCSVI with the highly respected Professors, Vascular consultants and other scientists who attended the conference and are at the forefront of treating the condition.
Having heard a talk by the MS Society on future MS treatments I have the distinct impression no one at the MS Society has read many of the source research papers on CCSVI. They appear to have no knowledge that doctors from 47 countries reached a consensus that CCSVI is a congenital venous malformation and set out diagnostic and treatment recommendations for the condition (IUP Consensus Document - there is a link to this in my Home Truths blog). Incidentally, Budd Chiari syndrome which is treated in the NHS (sometimes with balloon angioplasty!) can be caused by congenital venous webs in the venous outflow of the liver.
The MS Society also seems to be unaware that the Kuwaiti Govt is scanning and treating every PwMS in their country for CCSVI.
A Vascular Professor I know called the MS Society to ask how he might liaise with a neurologist on a possible research project to move this issue along in the UK. He got nowhere. The lights were on but nobody was home!
The Society has no interest in helping us with the discrimination we face, taking the vague line that 'more research is needed'. 15,000 of us have been treated, that rivals any drug trial. In essence, I believe the MS Society is a eunuch, castrated by the pervasive influence of the pharmaceutical industry.
The MS Society's Head of Biomedical Research appeared on an appallingly biased BBC television programme on Monday 7th March (Inside Out South West - CCSVI). He stated the following:
“going online to find information about unproven treatments can often be misleading”
“some websites make claims that aren't always evidence based”
“and personal testimonies unfortunately cannot replace properly controlled clinical trials”
The hypocrisy of the MS Society is breathtaking:
Botox Case Study
I am not aware of the Society criticising neurologists for prescribing many drugs off label to us including some epilepsy and Parkinsons drugs. There have been no double blind randomised controlled trials of those drugs specifically for PwMS that I am aware of.
It is interesting that in Biogen's literature given to patients presently on Tysabri they also advise against people believing anything they read on the internet and advise us that it is best we get our information from...... the MS Society!!
https://www.facebook.com/photo.php?fbid ... 27&theater
More of us will be needlessly crippled waiting for the pharmaceutical companies to finish buying up stent manufacturers so they can set the new prices for stents and they can tell the NHS when we might be allowed the treatment we require. Bayer's MS drugs haven't prevented anyone's ultimate disability from MS any better than any other MS drug (CRABS drugs fiasco in the NHS sums it up - hardly surprising as they are based on unproven assumptions about autoimmunity in MS!).
ms drug trial a fiasco and nhs paid for it
http://www.mddionline.com/article/bayer ... biomed-ltd
The UK is in an information time lag regarding CCSVI but may shortly move to the sort of situation as it is now in Canada. Canada has the complication that no private health care is allowed which means there is no pressure release valve there at all.
There are a couple of TV programmes on the subject of CCSVI in the course of production in the UK, perhaps you may even have been involved. When these are aired:
More people are going to go to GPs and ask to be investigated for CCSVI.
More people are going to go and get their own investigative scans and then approach the NHS for further investigation and treatment (as they cannot afford the cost of travelling abroad for actual treatment).
More people are going to travel abroad and risk being undertreated or partly treated.
Those travelling abroad will have no local follow up care. A UK Vascular Professor has already commented that this is going to be a 'bad mess'.
Almost everyone is going to be turned away by the NHS on vague grounds of funding, lack of evidence, etc etc Do we have the stenoses? If the answer is yes - do we have the techniques to safely treat the patient? The answer to the latter question is yes (but we will not do it if the patient has MS).
I have a copy of a letter written by Professor Naylor (President Elect of the Vascular Society of Great Britain) in which he states the following:
"The Vascular Society of Great Britain...... is fully aware of the anxieties felt by many patients with multiple sclerosis who feel that they may be being denied a therapeutic intervention. Until, however, the hypothesis proposed by Dr Zamboni is corroborated in large scale studies and randomised trials have demonstrated that venous angioplasty and stenting not only confers an improvement in the prognosis of MS patients but that the procedure can be done safely (note the complications highlighted within the Lancet Neurology Editorial) then it is unlikely that it will ever receive national funding within the UK".
All I would say here is thank God the poor children at Great Ormond Street aren't relying on Professor Naylor every time a surgeon picks up a scalpel to do something for the first, second or third time. He would have the poor child stitched up for a few years until they can find a sufficient number of children born without windpipes to carry out trials to decide whether it is a good idea to do something or not. Who gets to decide which of the children, who presumably all get their chests opened up to meet the 'blind' criteria, randomly gets their windpipe constructed and which do not.
Ah, but Professor Naylor would say it is different in a "life or death situation". Let's ask the family of this dear, brave lady about life and death situations.
"My mother in thought....."
She has probably lived with a congenital vascular malformation her whole life suffering long term hypoxia and brain lesions. Balloon angioplasty has been carried out on millions of people - why would Professor Naylor want someone like her to wait on randomised controlled trials when the founding father of angioplasty didn't even carry out such trials?
There is a Canadian legal campaign underway - "Angioplasty For All". Their lawyer's initial thoughts are set out on the following website: http://www.angioplastyforall.com/content.php?doc=26
There are many excellent points within the outline case.
What caught my eye is a point regarding "Evidence Based Medicine" which the lawyer refers to as follows:
"What I'm going to introduce in the court is the argument that if the Ontario government is true to its Evidence-Based Medicine principles, it will use a particular scientifically accepted approach to determining whether or not CCSVI angioplasty should be permitted."
And the approach that they should use is in this article from the journal PLOS Medicine, (http://www.plosmedicine.org/article/inf ... journal...
"When the Benefit/Harm ratio is very high, as I am going to argue it is in CCSVI, we do not need to be very certain that the procedure is valid. We do not need to be very certain at all. We need to be 10% certain that the procedure is valid, and then we should go ahead and do the procedure anyway."
"When we plug it in, we come up with the result that CCSVI angioplasty should be acceptable on very little empirical evidence."
Surely the decision making process of our doctors regarding venoplasty for PwMS need only address the benefit/harm ratio of carrying out any procedure on any patient. Such as the benefit/harm analysis carried out on children at Great Ormond Street who are not even able to sign their own consent forms for innovative procedures.
I find it astonishing for example that the following rare procedure is approved by NICE although the evidence supplied suggests that balloon angioplasty (with stents) in the pulmonary veins of these very sick infants is almost always futile.
http://www.nice.org.uk/nicemedia/live/1 ... /30997.pdf
The known risks of angioplasty (venoplasty) are minimal compared with the risk of disability from MS being allowed to progress unchecked. I was personally overjoyed to sign the consent form for my procedure.
How Ethical For Neurologists to Keep Prescribing Potentially Lethal DMDs without Venous Examination?
I think another big ethical question waiting to be answered could be - is it ethical for neurologists to continue to prescribe MS drugs, some of which are effectively chemotherapy with potentially lethal side effects, without at least also conducting a simple Doppler ultrasound and MRV to assess the patients' vascular system and offering minimally invasive balloon angioplasty as a treatment option.
Up to 15,000 of us have been investigated for CCSVI worldwide now and the statistics consistently indicate that at least 95% of us have stenosed IJVs and azygos veins whether the tests are carried out in the UK, Italy, Germany, Greece, Poland, US, Bulgaria, Kuwait, Egypt, Jordan etc etc. This cannot be a random event. At the very least one can deduce that MS and CCSVI are highly statistically correlated. I was tested for coeliac disease on the neurology ward because my neurologist had experienced one case of undiagnosed coeliac disease being associated with transverse myelitis. Given the numbers of us who have been treated for CCSVI surely neurologists cannot keep their heads in the sand about this for much longer.
Early treatment for CCSVI could prevent MS causing severe disability in the first place.
For many PwMS CCSVI treatment will be a 'therapy of last resort'. Even if it only offers some PwMS the chance of halting progression (rather than symptom reversal which some of us are fortunate to have) then for those with 'end stage' MS that chance alone is worth having. We need compassion brought into this debate immediately.
Many people with MS are already invisible to health professionals. Once a neurologist licks his finger and holds it up into the wind to determine that someone is Secondary Progressive or Primary Progressive then that patient has 'exhausted all options'.
For many PwMS treating their CCSVI will be 'that or nothing'. I believe that out of around 100,000 PwMS in the UK only 12,000 are on 'approved' disease modifying drugs - most of us don't even qualify for the chance to die from PML on Tysabri!
http://www.theyworkforyou.com/lords/?id ... 77#g1399.6
Contact with neurologists and other doctors often ends at the point where the patient ceases to be a candidate for DMDs - if you don't require drugs you don't require a neurologist anymore as they have nothing to offer you. Someone was recently 'discharged' by their neurologist after having MS for 22 years - presumably to just sit and wait for a wheelchair, carers and maybe a respite care home in due course?
There are people sitting in hospices and respite care homes right now with a 95% likliehood of undiagnosed and untreated stenoses in the veins that drain their brains.
I am very concerned that approximately 100,000 PwMS in the UK will be left to suffer needlessly because we are caught in the middle of a paradigm shift, the massive financial muscle of the pharmaceutical industry and politicians who unfortunately only listen to a Patient Body within the control of that industry.
Everyone with MS should be entitled to investigation and treatment for CCSVI in the NHS and we should surely not be discriminated against on the grounds of our MS.
Can you please help us? I would be most grateful if you could point me in the direction of any relevant legal cases.
With many thanks for your attention if you made it this far!